FDA Product Code
FDA Product Code JWY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.1640
510(k) Clearances — 441 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | 2026-04-21 | Traditional | PDF ↗ |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | 2026-04-17 | Traditional | PDF ↗ |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | 2025-10-02 | Traditional | PDF ↗ |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Thermo Fisher Scientific | 2025-09-25 | Traditional | PDF ↗ |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Thermo Fisher Scientific | 2025-09-05 | Traditional | PDF ↗ |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | Thermo Fisher Scientific | 2025-08-28 | Traditional | PDF ↗ |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem s.r.l. | 2025-08-20 | Traditional | PDF ↗ |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific | 2025-06-30 | Traditional | PDF ↗ |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Thermo Fisher Scientific | 2025-06-20 | Traditional | PDF ↗ |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | Biomérieux | 2025-06-12 | Traditional | PDF ↗ |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | Thermo Fisher Scientific | 2025-05-22 | Traditional | PDF ↗ |
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | Biomerieux S.A. | 2025-04-30 | Traditional | PDF ↗ |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific | 2025-04-15 | Traditional | PDF ↗ |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | Thermo Fisher Scientific | 2025-02-10 | Traditional | PDF ↗ |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | Thermo Fisher Scientific | 2025-02-10 | Traditional | PDF ↗ |
| K243202 | MTS Ceftobiprole 0.002-32 µg/mL | Liofilchem s.r.l. | 2025-01-30 | Traditional | PDF ↗ |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific | 2024-12-19 | Traditional | PDF ↗ |
| K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL | Thermo Fisher Scientific | 2024-12-05 | Traditional | PDF ↗ |
| K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL | Thermo Fisher Scientific | 2024-11-26 | Traditional | PDF ↗ |
| K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. | Thermo Fisher Scientific | 2024-10-09 | Traditional | PDF ↗ |
| K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | Thermo Fisher Scientific | 2024-10-01 | Traditional | PDF ↗ |
| K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. | Thermo Fisher Scientific | 2024-05-16 | Traditional | PDF ↗ |
| K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml | Thermo Fisher Scientific | 2023-10-31 | Traditional | PDF ↗ |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | Biomérieux | 2023-10-05 | Traditional | PDF ↗ |
| K231988 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml | Thermo Fisher Scientific | 2023-08-30 | Traditional | PDF ↗ |
| K231994 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL | Thermo Fisher Scientific | 2023-08-25 | Traditional | PDF ↗ |
| K230935 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) | Thermo Fisher Scientific | 2023-06-30 | Traditional | PDF ↗ |
| K230479 | ComASP Cefiderocol 0.008-128 | Liofilchem s.r.l. | 2023-05-18 | Traditional | PDF ↗ |
| K223844 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) | Thermo Fisher Scientific | 2023-03-21 | Traditional | PDF ↗ |
| K203741 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml | Thermo Fisher Scientific | 2021-12-20 | Traditional | PDF ↗ |
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | Biomerieux S.A. | 2021-11-12 | Traditional | PDF ↗ |
| K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL | Liofilchem s.r.l. | 2021-10-20 | Traditional | PDF ↗ |
| K202612 | Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) | Thermo Fisher Scientific | 2021-07-23 | Traditional | PDF ↗ |
| K202423 | MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) | Beckman Coulter, Inc. | 2021-05-18 | Special | PDF ↗ |
| K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) | Biomérieux SA | 2020-05-07 | Traditional | PDF ↗ |
| K200308 | MTS Lefamulin 0.016- 256 µg/mL | Liofilchem S. R. 1. | 2020-04-06 | Traditional | PDF ↗ |
| K200180 | MTS Omadacycline 0.002 - 32 ug/mL | Liofilchem s.r.l. | 2020-03-20 | Traditional | PDF ↗ |
| K193538 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml | Thermo Fisher Scientific | 2020-03-12 | Traditional | PDF ↗ |
| K193024 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL | Thermo Fisher Scientific | 2020-01-08 | Traditional | PDF ↗ |
| K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | Biomerieux S.A. | 2019-11-26 | Traditional | PDF ↗ |
| K192355 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) | Beckman Coulter, Inc. | 2019-11-14 | Traditional | PDF ↗ |
| K192729 | Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml | Thermo Fisher Scientific | 2019-11-06 | Traditional | PDF ↗ |
| K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL | Liofilchem s.r.l. | 2019-10-31 | Traditional | PDF ↗ |
| K192250 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL | Thermo Fisher Scientific | 2019-10-16 | Traditional | PDF ↗ |
| K192050 | ETEST Eravacycline (ERV) (0.002 32 µg/mL) | Biomerieux S.A. | 2019-09-27 | Traditional | PDF ↗ |
| K191908 | MTS Imipenem 0.016-256 µg/mL | Liofilchem s.r.l. | 2019-09-04 | Traditional | PDF ↗ |
| K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | Liofilchem s.r.l. | 2019-08-23 | Traditional | PDF ↗ |
| K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | Biomerieux S.A. | 2019-08-22 | Traditional | PDF ↗ |
| K190914 | MTS Doxycycline 0.016 - 256 µg/mL | Liofilchem s.r.l. | 2019-05-29 | Traditional | PDF ↗ |
| K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | Biomerieux S.A. | 2019-05-01 | Traditional | PDF ↗ |
| K190109 | MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) | Beckman Coulter, Inc. | 2019-04-18 | Traditional | PDF ↗ |
| K190252 | MTS Gentamicin 0.016 - 256 µg/mL | Liofilchem s.r.l. | 2019-03-22 | Traditional | PDF ↗ |
| K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL | Liofilchem s.r.l. | 2019-03-19 | Traditional | PDF ↗ |
| K183324 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL | Thermo Fisher Scientific | 2019-02-15 | Traditional | PDF ↗ |
| K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) | Biomerieux S.A. | 2019-01-11 | Traditional | PDF ↗ |
| K183140 | MTS Tetracycline 0.016 - 256 ug/mL | Liofilchem s.r.l. | 2019-01-11 | Traditional | PDF ↗ |
| K183033 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml | Thermo Fisher Scientific | 2019-01-04 | Traditional | PDF ↗ |
| K183115 | MTS Levofloxacin 0.002 - 32 µg/mL | Liofilchem s.r.l. | 2018-12-20 | Traditional | PDF ↗ |
| K182922 | MTS Omadacycline 0.002-32 µg/mL | Liofilchem s.r.l. | 2018-12-14 | Traditional | PDF ↗ |
| K182797 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL | Thermo Fisher Scientific | 2018-11-30 | Traditional | PDF ↗ |
| K182557 | MTS Eravacycline 0.002 - 32 µg/mL | Liofilchem s.r.l. | 2018-11-02 | Traditional | PDF ↗ |
| K181889 | MTS Penicillin 0.002- 32 µg/mL | Liofilchem s.r.l. | 2018-09-13 | Traditional | PDF ↗ |
| K181946 | Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL | Thermo Fisher Scientific | 2018-08-08 | Traditional | PDF ↗ |
| K181708 | MTS Plazomicin 0.016-256 µg/mL | Liofilchem s.r.l. | 2018-07-31 | Traditional | PDF ↗ |
| K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | Biomerieux S.A. | 2018-07-03 | Traditional | PDF ↗ |
| K180886 | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL | Liofilchem s.r.l. | 2018-05-18 | Traditional | PDF ↗ |
| K180339 | Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL | Liofilchem s.r.l. | 2018-04-04 | Traditional | PDF ↗ |
| K180330 | Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL | Liofilchem s.r.l. | 2018-03-15 | Traditional | PDF ↗ |
| K173817 | Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | 2018-02-28 | Traditional | PDF ↗ |
| K173307 | Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL | Liofilchem s.r.l. | 2017-12-19 | Traditional | PDF ↗ |
| K173209 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL | Thermo Fisher Scientific | 2017-12-01 | Traditional | PDF ↗ |
| K172542 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. | Liofilchem s.r.l. | 2017-10-23 | Traditional | PDF ↗ |
| K172454 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL | Thermo Fisher Scientific | 2017-10-13 | Traditional | PDF ↗ |
| K172109 | Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL | Liofilchem s.r.l. | 2017-09-27 | Traditional | PDF ↗ |
| K172150 | Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) | bioMerieux, Inc. | 2017-09-15 | Traditional | PDF ↗ |
| K172274 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL | Thermo Fisher Scientific | 2017-08-30 | Traditional | PDF ↗ |
| K171870 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 8 ug/mL | Thermo Fisher Scientific | 2017-08-01 | Traditional | PDF ↗ |
| K171906 | Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL | Liofilchem s.r.l. | 2017-08-01 | Traditional | PDF ↗ |
| K170772 | Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL | Liofilchem s.r.l. | 2017-06-07 | Traditional | PDF ↗ |
| K170670 | Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) | bioMerieux, Inc. | 2017-05-31 | Traditional | PDF ↗ |
| K170892 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL | Liofilchem s.r.l. | 2017-05-25 | Traditional | PDF ↗ |
| K163517 | Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL | Liofilchem s.r.l. | 2017-03-14 | Traditional | PDF ↗ |
| K163298 | Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL | Liofilchem s.r.l. | 2017-02-22 | Traditional | PDF ↗ |
| K162854 | Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml | Liofilchem s.r.l. | 2016-12-19 | Traditional | PDF ↗ |
| K161175 | Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL | Liofilchem s.r.l. | 2016-07-12 | Traditional | PDF ↗ |
| K153569 | Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml | Liofilchem s.r.l. | 2016-06-22 | Traditional | PDF ↗ |
| K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL | Liofilchem s.r.l. | 2016-03-31 | Traditional | PDF ↗ |
| K152774 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL | Thermo Fisher Scientific | 2015-12-21 | Traditional | PDF ↗ |
| K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | Biomerieux S.A. | 2015-10-07 | Traditional | PDF ↗ |
| K152346 | MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) | Beckman Coulter, Inc. | 2015-09-16 | Special | PDF ↗ |
| K150556 | Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) | Thermo Fisher Scientific | 2015-08-28 | Traditional | PDF ↗ |
| K150236 | Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) | Thermo Fisher Scientific | 2015-07-27 | Traditional | PDF ↗ |
| K143288 | Sensititre Susceptibility plates | Thermo Fisher Scientific | 2015-04-01 | Traditional | PDF ↗ |
| K143526 | The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) | Thermo Fisher Scientific | 2015-03-05 | Traditional | PDF ↗ |
| K142338 | Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) | Thermo Fisher Scientific | 2015-03-02 | Traditional | PDF ↗ |
| K143381 | Sensititre Susceptibility Plates | Thermo Fisher Scientific | 2015-02-19 | Traditional | PDF ↗ |
| K142151 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Thermo Fisher Scientific | 2014-12-23 | Traditional | PDF ↗ |
| K141651 | SENSITITRE SUSCEPTIBILITY PLATES | Thermo Fisher Scientific | 2014-10-21 | Traditional | PDF ↗ |
| K133847 | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES | Thermo Fisher Scientific | 2014-08-01 | Traditional | PDF ↗ |
| K141000 | SENSITITRE SUSCEPTIBILITY PLATES | Thermo Fisher Scientific | 2014-07-16 | Traditional | PDF ↗ |
Product code JWY · Class II · Microbiology. Data: openFDA.